NO316619B1 - Fat blend containing ß-sitosterol or ß-sitosterol and ß-sitostanol, a process for producing such a fat blend, using the same and a process for administering ß-sitosterol or ß-sitosterol and ß-sitostanol to lower serum tot - Google Patents

Description

The invention relates to a fat mixture containing P-sitosterol, or P-sitosterol and p-sitostanol, which lowers serum total cholesterol and LDL cholesterol levels, a method for producing such a fat mixture, the use thereof, and a method for supplying p-sitosterol, or p-sitosterol and p-sitostanol, to lower serum total cholesterol and LDL cholesterol levels, in food products.

A high total serum cholesterol level, hypertension and smoking are the main risk factors associated with a heart condition (1). There are several sterols of plant origin that differ from cholesterol only by side chain substituents and by the degree of saturation. Most of the higher plants produce 24α-substituted sterols (24-methyl- and 24-ethyl-sterols). Sitosterols are mixtures of p-sitosterol (stigmasa-5-en-3p-ole) and certain saturated sterols, such as p-sitostanol, which contain not less than 95% sterols, and unsaturated sterols not less than 85%. Sitosterols are largely present in plants, such as in wheat and rye germ oils, corn oil, and are common in seed oils. Sitosterols are antihyper-cholesterolemic agents that inhibit the absorption of cholesterol in the intestine, and through the inner walls of the blood vessels (2). Sitosterols play a role in the treatment of atherosclerosis when administered in doses of 2 - 3 grams, three times a day. day. In the Western diet, the daily intake of p-sitosterol, stigmasterol and campesterol from food is about 200 - 400 mg (3), which is about the same order of magnitude as our daily cholesterol intake from food.

By the early 1950s, it was recognized that as a result of the addition of p-sitosterol in the feed of cholesterol-fed chickens and rabbits, cholesterol levels were lowered in both test animals, and furthermore, this addition of p-sitosterol prevented atherogenesis in rabbits (4) . The use of sitosterol and soybean sterols to lower cholesterol levels was studied intensively in the 1950s and 1960s (5), and the resulting preparations actually lowered cholesterol levels by about 10% (6). It was then discovered that p-sitosterol activity was based on the inhibition of absorption of cholesterol, and that sterols of plant origin were themselves poorly absorbed (7). The mechanism that inhibits the absorption of cholesterol was thought to be based on the crystallization and co-precipitation of cholesterol and p-sitosterol. Mattson et al. (8) showed that one gram of p-sitosterol reduces the absorption of cholesterol from food containing 500 mg of cholesterol by 42%. The reduction in plasma cholesterol may be due to the increased activity of LDL receptors.

p-sitosterol is a lipophilic compound. In contact with the lipid membranes of the intestinal walls, p-sitosterol will not be absorbed due to its poor water solubility, or only a small part of it will be absorbed. When administered orally, only less will

than 5% be absorbed (9). P-sitosterol activity is based on competitive inhibition of cholesterol absorption in the intestines (10). p-sitosterol interferes with cholesterol absorption and re-absorption in the small intestine (11). It is assumed that this is due to the similarity between the chemical structures of cholesterol and P-sitosterol (12). Several studies conducted under different conditions have shown that phytosterols lower LDL cholesterol levels. It is further recognized that serum phytosterols correlate with HDL levels. p-sitosterol reduces the synthesis of cholesterol in the liver by affecting the gene production of HMG-CoA reductase (13). Richter W. et al (14) have shown that P-sitosterol lowers the total serum cholesterol level by 10 -15%, and the LDL cholesterol level by 19%, by inhibiting the absorption of cholesterol in the intestine. In one study, nine adult patients were given 500 mg of cholesterol for 5 days, as well as one gram of p-sitosterol, or two grams of p-sitosterol oleate. Cholesterol absorption was lowered by 42% when p-sitosterol was administered, and by 33% when p-sitosteryl oleate was administered (15). Uchita et al. (16) have found that sitosterol inhibits cholesterol absorption in female rats, and lowers the cholesterol balance in plasma and liver. Vahouny et al. (17) have found that sitosterol inhibits cholesterol absorption in rats by 54%.

Finnish patent application No. 964951 discloses an agent for lowering serum cholesterol levels and its use. This application concerns the use of an ester of p-sitostanol with a fatty acid or a mixture of esters with p-sitostanol with a fatty acid as a fat component or as a fat substitute in food products, its use as such, supplementation of the diet, and the composition itself.

Finnish Patent Application No. 98,730 discloses a method for producing a substance for lowering high serum cholesterol levels. The method uses p-sitostanol, made from p-sitosterol by hydrogenating in an organic solvent in the presence of palladium on carbon as a catalyst, and a vegetable oil to produce an ester of p-sitostanol with a fatty acid, or a mixture of such esters, using the trans-esterification technique in the presence of a sodium ethylate catalyst.

Both of the above patent applications disclose a process for modifying β-sitosterol to obtain a fat-soluble derivative thereof, wherein soluble β-sitostanol fatty acid esters are produced therefrom, as well as the use of the compositions obtained as agents for lowering serum cholesterol levels .

Naturally occurring p-sitosterol is a crystalline compound. As is known, free sterols, such as p-sitosterol, are only slightly soluble in oil and fat, and therefore derivatives of p-sitosterol, for example esters which are significantly more fat-soluble, are produced for practical reasons, although, according to some studies (15 ), these derivatives do not inhibit the absorption of cholesterol as effectively as the free p-sitosterol. Such fat-soluble derivatives can be mixed much more easily into nutritional products to form a homogeneous mixture than a solid, insoluble, coarse p-sitosterol powder. However, such processing to obtain a P-sitosterol derivative entails additional costs for the product. Furthermore, the hydrogenation of p-sitosterol to p-sitostanol is necessarily carried out using an organic solvent so that traces of this, as well as traces of the metal catalysts used, can be present in the esterified end product. In addition, the esterified product is no longer a naturally occurring substance, but a man-made artificial chemical composition.

US-A-3085939 relates to oil-in-water emulsions containing unsaturated oil and sitosterol. JP-A-62148424 relates to a sterol-containing composition for the food industry.

WO-A1-9742830 relates to a composition containing a liquid fat component and at least one sterol.

An object of the invention is to produce a method for producing a fat mixture of P-sitosterol, which is beneficial for health, homogeneous and stable, lowers total serum cholesterol and LDL cholesterol levels and contains P-sitosterol in a partially dissolved and/or in a microcrystalline form. Another object of the invention is to use such a homogeneous stable fat mixture of p-sitosterol containing this in a partially dissolved and/or in a microcrystalline form in fat preparations or food products as an agent that lowers the cholesterol level in serum, as well as to use this the mixture as such to complement the diet.

A method has thus been produced for producing a fat mixture of P-sitosterol, or of p-sitosterol and p-sitostanol, which lowers the serum total cholesterol and LDL cholesterol levels. The method is characterized by the fact that 10 - 30% by weight of a starting material containing p-sitosterol or p-sitosterol and p-sitostanol is dissolved in 5 - 90% by weight, preferably 60 - 85% by weight of oil, fat, or mixtures of oils and fats, by heating at a temperature of 80 - 140°C until the starting material containing p-sitosterol or P-sitosterol and P-sitostanol is dissolved, after which the mixture is cooled to a temperature of 40 - 80°C and where during the cooling it is added 5- 30% by weight of water with a temperature which is essentially equal to the temperature of the mixture, to the mixture, and the mixture is stirred whereby a homogeneous and stable mixture is obtained where the starting material containing p-sitosterol or p-sitosterol and p-sitostanol is in a partial dissolved and/or microcrystalline form.

Preferred features of the method according to the invention appear from claims 2-5.

A fat mixture containing P-sitosterol, or p-sitosterol and p-sitostanol, has also been produced, which lowers serum total cholesterol and LDL cholesterol levels. The fat mixture according to the invention is characterized in that the composition comprises 10-30% by weight of a starting material containing P-sitosterol, or p-sitosterol and p-sitostanol, 5-90% by weight, preferably 60-85% by weight of oil or fat or mixtures of these , and 5 - 30% by weight of water, and that the starting material containing p-sitosterol or p-sitosterol and p-sitostanol is in a partially dissolved and/or microcrystalline form, and that the composition is stable and homogeneous at room and refrigerator temperatures , based on physical assessments and assessments using the senses.

Preferred features of the fat mixture according to the invention appear from claims 7-10.

A method has also been developed for adding P-sitosterol, or P-sitosterol and p-sitostanol, to lower serum total cholesterol and LDL cholesterol levels in food products. The method according to the invention is characterized by the fact that 10 - 30% by weight of a starting material containing p-sitosterol or p-sitosterol and p-sitostanol is dissolved in 5 - 90% by weight, preferably 60 - 85% by weight of oil, fat or mixtures thereof by heating at a temperature of 80 - 140°C until the starting material containing p-sitosterol or p-sitosterol and P-sitostanol is dissolved, after which the mixture is cooled to a temperature of 40 - 80°C and where 5-30% by weight is added during the cooling water with a temperature which is essentially equal to the temperature of the mixture, to the mixture, and where the mixture is stirred whereby a homogeneous and stable mixture is obtained where the starting material containing p-sitosterol or p-sitosterol and p-sitostanol is in a partially dissolved and/or microcrystalline form, and where the resulting mixture is mixed into food ingredients in a food production process.

Applications of the fat mixture according to the invention appear from claims 11 and 12.

We have found that P-sitosterol can be made partially soluble and/or microcrystalline by the following procedure. The problems and disadvantages associated with the known technique can be avoided with the solution according to the present invention. According to the method of the invention, p-sitosterol and cooking oil are mixed, and this mixture is heated until all solids are dissolved in the oil. After cooling, water is added to the mixture at its temperature to thereby disperse it. The result will be a homogenous, stable, fat-like, so to speak, white mass with a consistency very reminiscent of butter, or an oily mixture, depending on the amounts of the components. This homogeneous and stable dough is particularly suitable for being mixed into, for example, food products.

The starting material in this method is p-sitosterol, which can contain 80-100% of P-sitosterol and P-sitostanol, and as impurities 0-20% of other sterols and stanols. This starting material contains p-sitosterol, or p-sitosterol can be mixed with the cooking oil in an amount of about 0.5 - 80%, preferably 10 - 30%, where the resulting dough-like product has an appearance and a viscosity that is very similar to the properties of butter, and is very easy to handle. The higher the percentage of p-sitosterol in the mixture, the harder the mass will be. On the other hand, if the amount of p-sitosterol in the mixture is less than 10% calculated from the amount of oil, the viscosity of the mass will decrease, and the consistency of this will clearly be more like an oil consistency. As a cooking oil, any cooking oil or any cooking oil or fat, or oil or an oil composition of animal origin, and suitable for human consumption, can be used, for example cod liver oil, or any edible oily substance of vegetable or animal origin, or mixtures thereof. Preferred oils are rapeseed oil, rapeseed oil, sunflower oil, soya oil, corn oil and olive oil. The amount of oil is 5 - 90%, preferably 60 - 85% in relation to the mass of the mixture.

In this method, a mixture of the starting material containing p-sitosterol and oil is heated at a temperature of 80 - 140°C, preferably 100 - 120°C, until the solid starting material containing p-sitosterol is dissolved in the oil. After the mixture has been cooled in a known manner to a temperature of 40 - 80°C, preferably to 50 - 70°C, water is added which essentially has the same temperature as the mixture. Texture-stabilizing surfactants, such as polysorbate (Tween 80, Polysorbate 80), egg lecithin, or soybean lecithin, known as emulsifiers, can optionally be added to the mixture in an amount of 0.05 to 8% by weight. If necessary, stabilizers, antioxidants or other suitable food additives known in the art can be added, such as sodium chloride, mineral salt, preservatives and flavourings, and/or various vitamins, for example vitamins A and E, food coloring and phytophenols. The mixture thus created is homogeneous and stable under conventional conditions for storing food products. In this mixture, the p-sitosterol is in a partially dissolved and/or microcrystalline form. If necessary, p-sitosterol can also be dissolved in an oil as described above, and this mixture of P-sitosterol and oil can be used as such in food production.

The method according to the invention makes it possible to produce, in a simple and economic way, a fat mixture of P-sitosterol which benefits health, which is homogeneous and stable and which reduces cholesterol absorption in the intestine, thereby lowering serum total cholesterol and LDL cholesterol levels, and contains the P-sitosterol in a partially dissolved and/or microcrystalline form. This method uses a naturally occurring p-sitosterol, and a cooking oil or fat, without any organic solvents or complicated process steps. Even large doses of the resulting homogeneous stable fat mixture containing a naturally occurring p-sitosterol can be safely consumed through food products on a daily basis, and used in food production and cooking to replace fat in part or in full. P-sitosterol cannot be detected using the senses from other food products. With the help of the food products prepared in this way, cholesterol absorption in the intestine can be inhibited, and the total serum cholesterol and LDL cholesterol levels can be significantly lowered. In addition, since p-sitosterol, which replaces fat, is not absorbed significantly, the proportion of absorbed fat is reduced, and thus energy intake is lowered.

A fat mixture containing P-sitosterol can be added to food products containing animal or vegetable oils, or mixtures thereof. Suitable food products are various processed meat products, such as sausages and sliced meats, processed fish products, food products that contain natural fatty acids, dairy products such as cheese, and several other food products that contain edible fats or mixtures thereof, such as sauces and dressings, mayonnaise, spices and spice mixtures, cereals, noodles and pasta products, ice cream, confectionery, chocolate, cakes, pastries and the like, as well as edible fats for cooking and baking, and mixtures thereof.

The invention will now be illustrated by means of some preferred embodiments which are described in the following examples. However, these examples are not intended to limit the invention only to these.

Examples.

Method for producing a mixture of p-sitosterol and fat, i.e. a so-called basic mixture.

In the examples, the starting material was a mixture containing p-sitosterol and p-sitostanol in a total amount of 89.2%, α-sitosterol in an amount of 0.1%, campesterol and campestanol in a total amount of 8.9% and artenols with a total amount of 0.9%. The starting material had a solids content of 98.8%, a melting range of 137 - 138°C and a density of 0.49 kg/dm<3>. For the sake of simplicity, this starting material is referred to in the following as "starting material containing p-sitosterol" according to its main component.

Example 1. Basic mixture containing p-sitosterol.

A mixture containing 20 wt% P-sitosterol and 80 wt% rapeseed oil was made. The mixture was heated with stirring in a glass jar until the starting material containing p-sitosterol was dissolved in the oil. At that point the temperature was about 110°C, and the test was carried out at normal atmospheric pressure.

After the mixture had cooled to about 60°C, tap water at the same temperature as the mixture (60°C) was added to it in an amount of about 15% in relation to the amount of the mixture, finely ground in a mortar.

The mixture was initially transparent and oily yellow when examined visually. When the addition of water was almost complete, the mixture suddenly became opaque and almost white. The mixture was allowed to cool to room temperature (22°C) with stirring. The final composition of the mixture is shown in Table 1.

Based on an examination by the senses, the mixture in Table 1 was a white, oily mass, with a consistency very similar to butter, and containing p-sitosterol in a partially dissolved and/or microcrystalline form. The mixture was practically tasteless. When stored in a refrigerator, the base mixture in Table 1 has remained unchanged, based on what can be perceived by the senses. So far, the mixture has been stored for about 6 months.

Example 2

Variation of the concentrations of the starting material containing P-sitosterol in the mixture containing oil and water

In the method in example 1, mixtures were made in which the proportion of the starting material containing P-sitosterol was 2.5 - 60% of rapeseed oil. It was observed that the consistency of the base mixture was most preferable when the starting material containing the P-sitosterol concentration was between 10% and 20%. The mixture then has an appearance and a viscosity comparable to butter, and is easy to handle.

The higher the proportion in the mixture of the starting material containing p-sitosterol, the harder the consistency of the mixture will be. Despite the hardness of the mixture, even high proportions of starting material containing p-sitosterol can be used, as described in example II (supply of starting material containing p-sitosterol to a pasta product).

Example 3

Preparation of the mixture using different cooking oils

Using the procedure in Example 1, mixtures were prepared in which rapeseed oil was replaced by sunflower oil, corn oil and olive oil. Blends were made with each of these oils using three different percentages of p-sitosterol: 5%, 10% and 20%.

Based on sensory and microscopic examination, the mixtures were similar to those made with rapeseed oil, except that the mixture containing olive oil had a greenish color. This suggests that all edible oils are very suitable for use in the method according to the invention.

Example 4

Addition of a surfactant to the basic mixture in example 1

It is generally known that surfactants are necessary for the preparation and stabilization of disperse systems, especially emulsions. It is often important to use surfactants which are able to stabilize the consistency of the dispersions, especially for long-term storage, for example to prevent any separation of the emulsion components, or a crystallization thereof.

The mixtures in Example 1 were essentially made, containing 2% by weight, calculated from the proportion of the water phase, of emulsifier commonly known as surfactants such as polysorbate (Tween 80, Polysorbate 80), egg lecithin or soybean lecithin. The resulting compositions were essentially as shown in Table I, but containing about 0.3% by weight of a surfactant.

Supply of a fat mixture containing P-sitosterol to a food product.

Example 5

Supplying the mixture described in Example 1 in traditional commercially available butter. 50% by weight of the basic mixture according to example 1 and 50% by weight of butter ("Meijerivoi of Valio", with a low salt content) were mixed in an ordinary steel mortar at room temperature (about 22°C). The mixing was easily done without any kind of difficulty.

Based on an evaluation by the senses, the result was a smooth, pale yellow mass with a color similar to butter that felt like ordinary butter in every way. The taste of the mixture was good and could not be distinguished from the taste of real butter, with the possible exception of a somewhat lower salt content.

Example 6

Supply of the mixture described in example 1 in a conventional commercially available rapeseed margarine 50% by weight of the base mixture according to example 1 and 50% by weight of rapeseed margarine ("Kultarypsi margariini 60", Van der Bergh, Sweden) were mixed together in an ordinary steel mortar at room temperature ( about 22°C). The mixture was somewhat softer, but otherwise with a consistency similar to that in example 3 above. The mixing was easily done without any difficulty.

Based on an assessment by the senses, the result was a smooth, pale yellow mass with a color similar to original canola margarine that felt like ordinary canola margarine in every way. The taste of the resulting product was good and indistinguishable from the taste of the initial margarine, with the possible exception of a somewhat lower salt content.

Example 7

Supply of the mixture described in example 1 in ordinary commercially available light margarine (light spread). 50% by weight of the base mixture in example 1 and 50% by weight of light margarine ("Kevyt Voilevi 40%" from Valio with a low salt content) were mixed together in an ordinary steel mortar. Mixing was done easily and without problems.

Based on a sensory assessment, the result was a smooth mass with a pale yellow color and a consistent feel similar to the initial light margarine used. The taste of the resulting mixture was good, and practically indistinguishable from the taste of the original margarine, with the possible exception of a somewhat lower salt content.

Example 8

Addition of salt (sodium chloride) to mixtures prepared as described in examples log 2.

Mixtures were made as described in examples 1 and 2, and 0.9% sodium chloride was added in relation to the final weight of the mass, using a known method. Based on a sensory assessment, the addition of salt did not impair the properties of these base mixes in any way.

Example 9

Assessment of the frying properties of the masses described above

The behavior of the mixtures containing butter or vegetable margarine described in Examples 5 and 6 was studied by simulated frying by frying them in cups. Frying pure butter and margarine was also studied, for the sake of comparison. The mixture containing light margarine was not fried because light margarine used as a starting material is not intended for frying.

9. 1 Butter as such

Initially, when pure butter was heated, it formed a bright yellow oil with few bubbles. As heating continued, brown precipitates appeared. This is how butter usually turns brown.

9. 2 Mixture containing butter and p-sitosterol

When frying the mixture in Example 5, it melted somewhat more slowly and melted more than butter heated in the same way. In the same way as butter, a strongly yellow colored oil formed. As the heating continued, brown spots of the same color as those appearing in the butter, but of a smaller size, appeared. This suggests that said mixture in example 5 is just as suitable for frying as commercially available types of butter.

9. 3 Margarine as such

Pure margarine also formed a clear yellow colored oil when melted. It melted more than butter when heated. When heated, brown spots appeared, as in the mixture in example 5 which contained butter and the base mixture in example 1.

9. 4 Mixture containing margarine and p-sitosterol

When the mixture in Example 6 was fried, it was observed that it behaved in the frying test in the same way as pure margarine and essentially in the same way as the mixture in Example 5. This indicates that the mixture is as suitable for heating as commercially available margarine types .

9. 5 Conclusions on the tests in example 9

In this frying test, the differences in fat browning appeared to be due to the type of fat used (butter or canola margarine) and were not due to the presence of the base mixture containing P-sitosterol.

Example 10

Supply of the mixture described in example 1 to dairy products

50% by weight of the base mixture in example 1 and 50% by weight of mayonnaise (Heinz Mayonnaise, H.J. Heinz B.V., Holland) were mixed together in an ordinary steel mortar at room temperature (about 22°C). The mixture was mixed together in the same way as with a sour cream product (Smetana from Valio) and with a cream cheese product (Hovi cream cheese from Valio). The mixing of these food products was carried out easily and without difficulty of any kind.

Example 11

Supply of the starting material containing P-sitosterol to a pasta product

β-sitosterol was heated with the amount of oil necessary for paste preparation until either β-sitosterol dissolved in oil or an opalescent uniform flowing liquid was formed, depending on the ratio of β-sitosterol to oil. This liquid was allowed to cool while it was finely ground. The resulting cooled mixture was added with either water, or an egg mixture and water, or an egg mixture while simultaneously grinding to create an emulsion. An appropriate amount of durum wheat flour (hard wheat) and salt was then added by kneading the dough. Water was added as needed while the dough was being kneaded. The result was a uniform paste in which P-sitosterol could neither be detected visually nor tasted. The amount of p-sitosterol in the pasta was as much as 2 g/100 g of fresh pasta. Amounts exceeding this are not necessary, taking into account the weight of a portion of pasta (125 g of fresh pasta per portion) and when taking into account the appropriate concentration of P-sitosterol for its activation. Table 2 shows examples of pasta dough compositions.

Pasta flakes were made in the usual way from this pasta dough. The pasta can be served either

as fresh pasta or it can be dried for long-term storage. Both fresh and dried pasta products were boiled in plenty of water for as long as 10 minutes. P-sitosterol was not released from the pasta either into the boiling water or into the rinse water used on the cooked pasta.

The properties of the pasta corresponded completely to those of ordinary pasta prepared without P-sitosterol.

1) The appropriate amount of water may vary depending on, for example, the type of durum wheat flour.

Example 12

Supply of the base mixture containing P-sitosterol in pizza

The pizzas were baked at 225°C for about 25 - 30 minutes.

The properties of the pizza containing β-sitosterol completely corresponded to the properties of the pizza made without β-sitosterol.

Example 13

Supply of the base mixture containing p-sitosterol in meatballs

The meat mixture did not stick to the hands, and the properties of the meatballs containing p-sitosterol were comparable to the properties of the ordinary meatballs without p<->sitosterol.

Example 14

Supply of the base mixture containing P-sitosterol to rolls

The base mixture containing p-sitosterol could very well be mixed into the dough and the dough was easy to handle and knead, as it was not sticky. The properties of the rolls containing P-sitosterol completely matched the properties of the rolls made without P-sitosterol.

Example 15

Adding the base mixture containing P-sitosterol to a sauce made with milk

Fat was melted in a saucepan, and flour was then mixed in. The mixture was brought to a boil, and cold milk was added in two portions. The fat was well and evenly mixed into the sauce. The properties of the milky sauce in which the fat was replaced with the base mixture containing p-sitosterol fully corresponded to the properties of the sauce prepared using ordinary fat.

References:

1) Jousiiahti P, Vartiainen E. Tuomiiehto J, Puska P: The Lancet 348/9027), pp. 567-572. 1996 2) Claus EP, Tyler VE & Brady LR: Pharmacognosy 6th edition. Lea & Febiger, London, 1970, pp. 165-157 3) Jones PJH et al. : Canadian Journal of Physiology & Pharmacology 75(3): 217-227, 1997

4) Pollak OJ, Kriichecsky D: Monogr Atheroscler. 10: 1—219. 1981

5) Vahoyny GV, Kritchavsky D.: Plant and marine sterols and cholesterol metabolism. ln Spiller GA, ed. Nutritional Pharmacology. New York, NY:

Alan R Liss Inc; 1981 pp. 31-72

6) Vahoyny GV, Kiitchevsky D.: Plant and marine sterols and cholesterol metabolism. ln Spiller GA, ed. Nutritional Pharmacology. New York NY:

Alan R Liss Inc: 1981 pp. 31-72

7) Tilvis RS, Miettinen TA: Am J Clin Nutr.: 43; 92—97, 1986

8) Martson FH; Grundy SM, Crouse JR: Am J Clin Nutr. 35, 697-700, 1982 9) Steinegger E & Hånsel R: Pharmacognosie, 5. Aufl., Springer-Lehrbuch,

Berlin-Heidelberg-New York, 1992, p. 195

10) Hånsel R & Haas H.: Therapie mit Phutopharmaka, Springer-Verlag, Berlin-Heidelberg-New York-Tokyo, 1983 pp. 187-188 11) - Hånsel R: Phutopharmaka, Grundlagen und Praxis, 2. Auflage, Springer- Veriag, Berlin-Heidelberg-New York, 1991 pp. 192-193 12) Jones PJH et al. : Canadian Journal of Physiology & Pharmacology 75(3): 217-227, 1997

13) Field, FJ et al. : Journal of Lipid Research. 38(2): 348—360, 1997

14) Richter W et al. : Current Research. 57(7): 497—505, 1996

15) Mattson FH et al. : American Journal of Clinical Nutrition. 35(4): 697-700, 1982 16) Uchita E et al. : Japanese Journal of Pharmacology. 33(1): 103-12, 1983 17) Vahouny GB et al. : American Journal of Clinical Nutrition. 37(5): 805—9. 1983

Claims (13)

1. Process for producing a fat mixture of P-sitosterol, or of p-sitosterol and P-sitostanol, which lowers the serum total cholesterol and LDL cholesterol levels, characterized in that 10-30% by weight of a starting material containing p-sitosterol or P-sitosterol and P-sitostanol is dissolved in 5 - 90% by weight, preferably 60 - 85% by weight of oil, fat, or mixtures of oils and fats, by heating at a temperature of 80 - 140°C until the starting material containing p-sitosterol or p-sitosterol and p-sitostanol is dissolved, after which the mixture is cooled to a temperature of 40 - 80°C and where, during the cooling, 5-30% by weight of water with a temperature which is essentially equal to the temperature of the mixture is added to the mixture, and the mixture is stirred whereby a homogeneous and stable mixture is obtained where the starting material containing p-sitosterol or P-sitosterol and P-sitostanol is in a partially dissolved and/or microcrystalline form. 2. Method according to claim 1, characterized in that the oil or fat is any edible oil substance of vegetable or animal origin, or a mixture of these. 3. Method according to claim 1 or 2, characterized in that the oil comprises sunflower oil, rapeseed oil, tumid oil, soya oil, olive oil or corn oil. 4. Method according to claims 1-3, characterized in that in the method a surfactant, an emulsifier, polysorbate, lecithin of vegetable or animal origin, or a mixture of these, is added to the mixture. 5. Method according to any one of claims 1-4, characterized in that a food additive, sodium chloride, mineral salt, preservative or flavor additives or vitamins, such as vitamins A and E, or mixtures thereof are added to the mixture. 6. Fat mixture containing p-sitosterol, or p-sitosterol and p-sitostanol, which lowers serum total cholesterol and LDL cholesterol levels, characterized in that the composition comprises 10-30% by weight of a starting material containing p-sitosterol, or p-sitosterol and p-sitostanol , 5-90% by weight, preferably 60-85% by weight of oil or fat or mixtures thereof, and 5-30% by weight of water, and that the starting material containing P-sitosterol or P-sitosterol and p-sitostanol is in a partial dissolved and/or microcrystalline form, and that the composition is stable and homogeneous at room and refrigerator temperatures, based on physical assessments and assessments using the senses. 7. Fat mixture according to claim 6, characterized in that the oil or fat is any edible oil substance of vegetable or animal origin, or a mixture of these. 8. Fat mixture according to any one of claims 6 or 7, characterized in that the oil comprises sunflower oil, rapeseed oil, turnip oil, soya oil, olive oil or corn oil. 9. Fat mixture according to any one of claims 6 - 8, characterized in that the composition comprises a surfactant, an emulsifier, polysorbate, lecithin of vegetable or animal origin, or a mixture of these. 10. Fat mixture according to any one of claims 6-9, characterized in that the composition comprises any food additive, sodium chloride, mineral salt, preservative or flavor additives or various vitamins, such as vitamins A and E, or mixtures thereof. 11. Use of the fat mixture according to any one of claims 6 - 10 in food products, in food oils and fat products, such as butter, in fat mixtures containing butter, in light fatty spreads, in vegetable margarine, and in various mixtures of these, such as well as in fatty products for cooking and baking. 12. Use of the fat mixture according to any one of claims 6 - 10 in food products, in food products comprising fat products of animal or vegetable origin or mixtures thereof, such as processed meat and fish products, in food products containing natural fatty acids, in dairy products, in food products containing edible fat products or mixtures thereof, for example sauces and dressings, spices and spice mixtures, cereal products, ice cream, confectionery, chocolate, cakes and pastries. 13. Process for adding p-sitosterol, or P-sitosterol and p-sitostanol, to lower serum total cholesterol and LDL cholesterol levels, in food products, characterized by atl0-30% by weight of a starting material containing P-sitosterol or p-sitosterol and P -sitostanol is dissolved in 5 - 90% by weight, preferably 60 - 85% by weight of oil, fat or mixtures thereof by heating at a temperature of 80 - 140°C until the starting material containing p-sitosterol or p-sitosterol and p-sitostanol is dissolved , whereupon the mixture is cooled to a temperature of 40 - 80°C and where, during the cooling, 5-30% by weight of water with a temperature which is essentially equal to the temperature of the mixture is added to the mixture, and where the mixture is stirred whereby a homogeneous and stable mixture where the starting material containing P-sitosterol or p-sitosterol and p-sitostanol is in a partially dissolved and/or microcrystalline form, and where the resulting mixture is mixed into food ingredients in a food production process .